FDA Recall D-0994-2015
REFA Enterprises, LLC · Virginia Beach, VA
Class I — life-threatening Terminated 366 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Forever Beautiful BEE POLLEN, capsules, 250mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Recall record
- Recall number
D-0994-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2014-11-03
- Classified by FDA Center
- 2015-05-06
- FDA published
- 2015-05-13
- Terminated
- 2015-11-04
- Recalling firm
- REFA Enterprises, LLC
- Firm location
- Virginia Beach, VA